What is NDC 16571-657?

16571-657 is the product NDC for Cevimeline Hydrochloride, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cevimeline Hydrochloride?

16 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cevimeline Hydrochloride NDC 16571-657

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-657Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0657Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
16571-657-10	16571065710	100 CAPSULE in 1 BOTTLE (16571-657-10)Marketed from Jun 17, 2014

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Cevimeline Hydrochloride
Generic name (nonproprietary): cevimeline hydrochloride
Active ingredients: Cevimeline hydrochloride — 30 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203775
Marketing start: Jun 17, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Agonists (Mechanism)
Identifiers: Product ID 16571-657_640e50a9-48ba-45e3-a3cb-c14bb313cc4fSPL ID 640e50a9-48ba-45e3-a3cb-c14bb313cc4fSPL set ID d4bd942a-1339-40c5-8fd4-850da5a69635RxCUI 309140UNII P81Q6V85NPUPC 0316571657100
Pharmacologic class: Cholinergic Receptor Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N416571065710 followed by a unit qualifier and the quantity

Package 16571-0657-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Aug 2, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-657

What is NDC 16571-657?: 16571-657 is the product NDC for Cevimeline Hydrochloride, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cevimeline Hydrochloride.
What is the active ingredient?: Cevimeline hydrochloride.
Who is the labeler?: Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cevimeline Hydrochloride?: 16 other product NDCs are listed under this name. See all Cevimeline Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cevimeline Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Viona Pharmaceuticals Inc	72578-208	72578-0208-01
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1982	70771-1982-01
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Macleods Pharmaceuticals Limited	33342-216	33342-0216-11
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-422	59651-0422-0159651-0422-05
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2563	72162-2563-01
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2326	71335-2326-0171335-2326-0271335-2326-03
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Advagen Pharma Ltd	72888-118	72888-0118-0072888-0118-0172888-0118-05+1 more
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-457	72789-0457-0172789-0457-30
cevimeline hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-3168	71335-3168-0171335-3168-0271335-3168-03
cevimeline hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Cosette Pharmaceuticals, Inc.	0713-0937	00713-0937-01

All 17 Cevimeline Hydrochloride NDCs

Other NDCs under ANDA 203775

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203775
Product	Strength	Form · route	Labeler	Product NDC
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	ASCLEMED USA INC.	87063-180
Cevimeline Hydrochloride	Cevimeline hydrochloride 30 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-9863